I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

To Address The Dementia Epidemic, We Need Smarter Research Funding

Government ministers, public health advocates, scientists and drug industry executives from the Group of Eight leading economies held a special summit meeting in London last week to devise a strategy to address what amounts to a global epidemic of dementia.

Dementia, the most common form of which is Alzheimer’s disease, currently affects 44 million people worldwide and is expected to afflict triple that number by 2050. There are no effective drug treatments for Alzheimer’s disease, and scientists’ understanding of the pathophysiology of the disease is, to be charitable, incomplete.

Predictably, and justifiably, many of the speakers cited the need for increased basic research and drug development. The Summit Declaration, which was signed by the G8 health and science ministers, called for, among other things, an “increase collectively and significantly [in] the amount of funding for dementia research” in order “to identify a cure or a disease-modifying therapy for dementia by 2025.”

But with fiscal austerity in vogue in most, if not all, the G8 countries, research funding is under pressure and has largely become a zero-sum, or even a negative-sum, game. Bruce Alberts—editor of the journal Science and former president of the U.S. National Academy of Sciences—lamented recently the National Science Foundation’s announcement that “it may award 1000 fewer research grants in 2013 than it did in 2012.”

So where are the needed new resources to be found? The dirty little secret that underlies current U.S. government research funding is that a vast amount of money is wasted. Too much of what is dispensed is pork, overlaps with work that would otherwise be performed in the private sector, or supports poorly conceived or trivial experiments. In fact, there are plenty of resources that could be profitably redirected, if only legislators and policy makers had the courage to make some tough decisions.

Public funding for scientific investigations should largely be limited to basic research or proof-of-principle experiments—which can be justified on the grounds that they are public goods. Federal research also should follow recognized experimental methodologies and focus on nontrivial questions or problems. Unfortunately, these seemingly obvious criteria are often sacrificed on the altar of scientific fads and political correctness.

The National Science Foundation is an example. A major driver of American science with an annual budget of over $7 billion, the NSF funds about one-fifth of all federally supported basic research at U.S. colleges and universities and 60% of all non-biomedical life-science research. Yet a 2011 report, “NSF Under the Microscope,” released by Sen. (and physician) Tom Coburn (R., Okla.) identified projects that should shock many Americans, scientists and nonscientists alike.

These studies include: how to ride a bike; when dogs became man’s best friend; whether political views are genetically predetermined; trends in the names chosen for babies; and why the same teams always seem to dominate the NCAA basketball tournament. More recent studies funded by the NSF include “how power affects empathy” and an assessment of “the role of optimism and pessimism in shaping the political beliefs and behavior of Americans.”

Most of these ill-advised projects are funded by the science foundation’s Social, Behavioral and Economics Directorate. The social sciences grants were evaluated with more rigor when they were organizationally within the NSF’s Biology Directorate. When these grants were split off, scientific rigor gave way to cronyism and narcissistic self-regard. A former senior NSF official characterized the current situation as “the inmates running the asylum.” The result is deranged peer-review.

Another example is the National Center for Complementary and Alternative Medicine at the National Institutes of Health, which is plagued by a flawed mandate and the breakdown of effective peer review. NCCAM’s mission is “to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care.” But as infectious-disease specialist Dr. Paul Offit has written, “There is no such thing as alternative medicine. There’s only medicine that works and medicine that doesn’t.”

Few, if any, of the center’s projects are at the cutting edge of medicine. For example, one NCCAM-funded study published in 2011 found that cranberry juice cocktail was no better than placebo at preventing recurring urinary-tract infections. Other studies include, “Metabolic and Immunologic Effects of Meditation,” “Long-Term Chamomile Therapy of Generalized Anxiety Disorder,” and “Restorative Yoga for Therapy of the Metabolic Syndrome.”

Much of the research funded by NCCAM, to the tune of $130 million annually, is an affront to NIH-funded investigators who are leaders in disciplines like cell and molecular biology, immunology and infectious diseases—but who are having increasing difficulty getting federal funding even for studies with obvious scientific merit.

Yet another federal research boondoggle is the USDA’s multi-million dollars per year program on risk-assessment for “genetically engineered organisms,” run the by National Institute of Food and Agriculture. Guided (one would hope) by innumerable analyses by the National Research Council, National Academy of Sciences, academics and others, in the United States and abroad, the USDA has had decades to figure out that “genetically engineered organisms” do not represent a meaningful category amenable to risk analysis (or deserving of discriminatory, excessive regulatory oversight, which is another story). There is no scientific rationale for a dedicated set-aside for risk-assessment research on this pseudo-category of organisms. It’s like doing risk-assessment on all the objects that have doors. And yet, as recently as last week, USDA’s NIFA published a request for grant proposals concerning “the effects of introducing into the environment genetically engineered organisms.” This is both wasteful and shameful.

Because money is fungible – and these days, in short supply — federal agencies are, in effect, funding research on baby-naming and meditation therapy at the expense of science’s Next Big Thing. Organizations within major research funding agencies have shown themselves to be systematically incapable of discerning which projects are potentially important and which are trivial. If we are serious about doing more and better scientific research on the critical medical problems of an aging population, such as dementia, cancer and pathogens resistant to antibiotics, we need to be more discriminating.

Congress should strip unworthy federal organizations of the ability to dispense research funds. Paraphrasing the old Smith Barney TV ad from the 1970’s, research grants should be awarded the old-fashioned way: Researchers need to earn them – by proposing worthy, non-trivial projects that will be performed using sound methodology.

However, legislators are constantly being importuned for increased across-the-board funding, which is unlikely to materialize. What we will see, however, are skyrocketing healthcare costs, as ever more dementia patients need supportive care – and receive it as part of federal entitlement programs.

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I am a graduate research associate in molecular cell biology. I agree that funding should be restricted to projects with scientific merit and some of your objections are valid. However, you attack research in the ‘soft sciences’ like GAD and meditation without providing a reason why you think that such research is “an affront” to the more ‘hard sciences’ of biochemistry and molecular biology. How are we to know if there is an effect of these therapies or not unless there is research done in this area and how can we do research in this area unless we are open to knowing if there is an effect from these non-drug therapies?

I am a professor working on genetic engineering of plants. I agree that the release of transgenics is over-regulated. However, we have to face the fact, simply denying the existing system does not help anything. It is unfair to criticize the Risk Assessment program. Worldwide, GMO plants have been tightly regulated partially due to public concerns about biosafety. Deregulation of transgenics is the most complicated and costly process in bringing new technology to the market, and this has created monopoly of big companies. Publically funded projects are needed to provide credible information to regulatory agencies and the public. The Risk Assessment program has been very valuable in providing such information. In theory, the deregulation should become simpler over time, unfortunately, if we look back what happened in the past ten years, the deregulation process has become more complicated due to various reasons. There are things that USDA cannot control; the deregulation-re-regulation-deregulation process of transgenic alfalfa is a good example. It is not trivial to do an environmental impact statement, and it will be more problematic for minor crops without public funding.

You appear to be unfamiliar with the unfortunate history of the unscientific and excessive regulation of recombinant DNA-modified plants by USDA. In fact, the approach to regulation is, and was, something that USDA CAN control.

By concocting the nonsensical and non-risk-based category of “regulated articles,” USDA created a situation in which every deregulation is a federal “major action,” which triggers NEPA, the National Environmental Policy Act. That has made possible the proliferation of lawsuits claiming that USDA failed to meet its obligations under NEPA (including the alfalfa situation to which you alluded).

In fact, the problems of regulation are due to the shortsightedness, cupidity and stupidity of the bureaucrats during the 1980s. For a more detailed explanation, see http://www.forbes.com/sites/henrymiller/2013/08/14/activists-vindicated-genetic-engineering-produces-a-genuine-monstrosity/.

A far more scientific, risk-based and appropriate approach to the regulation of recombinant DNA-modified plants would have been something along that lines of the model described in http://www.nature.com/nbt/journal/v15/n9/abs/nbt0997-845.html.